KWARA STATE UNIVERSITY MALETE

FACULTY OF PURE AND APPLIED SCIENCES

DEPARTMENT OF MICROBIOLOGY

COURSE: MCB 881 (ADVANCED PHARMACEUTICAL

MICROBIOLOGY)

SCREENING FOR THE SAFETY OF ANTIBIOTICS

BY

AYILARA BALQEES FOLAKE 23/57MMB/024

ISIAKU HUSSAIN YAKUB 23/57MMB/014

ABDULAKEEM KUNLE ADELORE 23/57MMB/025

LECTURER IN CHARGE

PROFESSOR SUNDAY AWE

INTRODUCTION
 Antibiotics are chemical substance produced by microorganisms which either
inhibit the growth of other microorganisms or kill them when applied in small
concentration.The production of antubiotics involves:

1.Isolation and selection of the organism

2.Fermentation on suitable medium for the production of antibiotic.

3.Extraction

4.Purification

5.Crystallization.

The isolation of microorganisms for antibiotic production can mainly be done by

screening.

Screening may be defined as the use of highly selective procedures to allow the detection and
isolation of only those microorganisms of interest from among a large microbial population.
Its essence is to select therapeutic effects while minimizing adverse effects thereby ensuring
safety in subsequent stages of drug .

The two major forms of screening approaches are:

1.primary screening

2.secondary screening .

Primary screening:This involves screening of antibiotic producers by employing various

methods like the crowed plate method,direct soil inoculation method,the cross streak
method,agar plug method and the replica plating method.

Secondary screening:After antibiotics has been identified from primary screening, secondary
screening is followed to establish the safety of such antibiotics. Safety assessment of
antibiotics is very crucial prior to their approval for human use.

The screening tests are:

1. Toxicity test
 2. Stability test
3. Heamolytic test
4. Heat and acid stability test
5. Teratogenicity test

1. TOXICITY TEST

Toxicity is the quality of being toxic or poisonous, the toxicity of of a drug depends
on its dosage

Toxicity test is normally carried out to ascertain the toxicity level of the new
antibiotics. It is carried out by injecting known concentration of the antibiotics into
experimental rats the rats are then observed for death or any other abnormal characteristics. It
often involves the use of cell cultures or model organisms with common tests such as
cytotoxicity assays and animal studies to evaluate potential harmful effects before advancing
to human trials.The rats are observed for the first four hours,24hrs, and daily for 14days.the
total number of death should be recorded ,and the signs that should be observed and recorded
during toxicity testing are:Analgesia,tremors,lacrimation,salivation,depression,
sedation,stimulation etc.

2. STABILITY TEST

Stability is the quality or state of being stable, something that is not easily changed, i.e
the state of antibiotics when exposed to different environmental conditions.

Stability testing for antibiotics involves assessing how well the drug retains its
potency and integrity overtime, under various conditions. This includes studying factors like
temperature, humidity, and exposure to light. This test is important for antibiotics that are
administered orally. It involves subjecting the antibiotics to extracts from digestive systems
and other organs of the body after which the antibiotics is assay for activity. The results from
these tests help ensure the antibiotic’s effectiveness and safety throughout its intended storage
and use

3. HEMOLYTIC TEST

Haemolysis is the destruction of red blood cells (erythrocytes). Red blood cells are an
essential part of the blood, they carry out oxygen from the lungs to tissue throughout the
body. The body uses this oxygen to make energy available to perform essential functions.
When the red blood cells then get destroyed too quickly before the body replace them thereby
making the body to have two red blood cells because of haemolysis causes a condition called
haemolytic anaemia

Haemolytic test is carried out to determine the ability of the antibiotics to cause lysis
of the red blood cell. This test is crucial for evaluating the safety of drugs to prevent adverse
effects on blood components, in the context of antibiotic screening, it helps determine if the
antibiotic has haemolytic effect, which could lead to issues like anaemia or other blood
related complications in patients, It is carried out by introducing known quantity of the
antibiotics into blood agar, the agar is then observed for zone of clearance around the point of
introduction of the antibiotics.

4. HEAT AND ACID STABILITY TEST

This test is carried out to determine the stability of the antibiotics when exposed to
high temperature and extreme acidity. In temperature stability test, the antibiotics are exposed
to temperature higher than the normal body temperature at the end of exposure the antibiotics
is tested for activities. The antibiotic can also be exposed to acidic environments mimicking
stomach conditions this is to determine if the drug remains stable and active despite exposure
to low pH levels, which is crucial for oral medications. In acidity pH value ranging from 1-12
at the end of exposure, the antibiotics is tested for activity

5. TERATOGENICITY TEST

Teratogenicity is the study of abnormalities of physiological development in

organisms during their life span teratogenicity

Teratogenicity test is carried out to determine the effect of the antibiotics on

developing fetus. The test is carried out by injecting pregnant animals with known
concentration of the antibiotics the animals are then examine for abortion or abnormality in
young ones that are born. These tests are crucial for evaluating the safety of drugs, especially
for pregnant individuals. Ethical considerations require rigorus testing to ensure that
medications, including antibiotics do not pose teratogenic risks during pregnancy